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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea

NCTNCT01557166 (opens ClinicalTrials.gov in a new tab)Other idNN8022-3970Other idU1111-1126-6260
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
359 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
2 countries

United States, Canada

Start
7 Jun 2012
Primary completion
1 Jun 2013
Completion
17 Jun 2013
First posted
19 Mar 2012 (estimated)
Last update posted
1 Nov 2017
Conditions
Metabolism and Nutrition Disorder · Obesity · Obstructive Sleep Apnoea

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 3

    Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea

    NCT01557166

    7 Jun 2012 to 17 Jun 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted in North America. The aim of the trial is to investigate the effect of liraglutide in obese subjects with sleep apnoea.

Interventions

  • liraglutideDrug
  • placeboDrug

Arms2

  • Experimental

    Liraglutide 3.0 mg

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Apnoea-hypopnoea Index (AHI)

    Time frame · Week 0, Week 32

    Registry description

    Observed mean change from baseline in AHI (events/hour) after 32 weeks of treatment. AHI (apnoea and hypopnoea events per hour of sleep) is a measure used for the diagnosis and severity classification of obstructive sleep apnoea. AHI severity category: none ≤4.9; mild 5.0-14.9; moderate 15.0-29.9; severe ≥30.0 events/hour.

Secondary outcomes(3)

  1. Change From Baseline in Body Weight (kg)

    Time frame · Week 0, week 32

    Registry description

    Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.

  2. Change From Baseline in Fasting Plasma Glucose

    Time frame · Week 0, week 32

    Registry description

    Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment.

  3. Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)

    Time frame · Week 0, week 32

    Registry description

    Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 0, Week 32

Change From Baseline in Apnoea-hypopnoea Index (AHI)

GroupValue (events/hour)Spread
Liraglutide 3.0 mg-12.2223.34
Placebo-6.0825.90
Secondary and other outcome results(3)
Secondary outcomeMean· Week 0, week 32

Change From Baseline in Body Weight (kg)

GroupValue (kg)Spread
Liraglutide 3.0 mg-6.736.59
Placebo-1.875.44
Secondary outcomeMean· Week 0, week 32

Change From Baseline in Fasting Plasma Glucose

GroupValue (mmol/L)Spread
Liraglutide 3.0 mg-0.150.69
Placebo0.170.96
Secondary outcomeMean· Week 0, week 32

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)

GroupValue (percentage of glycosylated haemoglobin)Spread
Liraglutide 3.0 mg-0.360.30
Placebo-0.170.29

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutide 3.0 mgSubjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.–6 / 176117 / 176
PlaceboSubjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.–6 / 17984 / 179

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Meta-analysis (pooled) · 2018

2 results

Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials.

Davies et al. 2018Diabetes, obesity & metabolismcited by 80

PMID 28950422PMC5836948DOI 10.1111/dom.13125PUB-28950422

Free to read · publisher termsCC BY-NC2 results
Read at sourceSee results (2)

Indexing hint: Randomized controlled trial · 2016

6 results

Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical trial.

Blackman et al. 2016International journal of obesity (2005)cited by 398

PMID 27005405PMC4973216DOI 10.1038/ijo.2016.52PUB-27005405

Free to read · publisher termsCC BY-NC-ND6 results
Read at sourceSee results (6)

Indexing hint: Randomized controlled trial · 2016

8 results

EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS.

O'Neil et al. 2016Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 18

PMID 27482610DOI 10.4158/ep151181.orPUB-27482610

Full text at the publisher8 results
Publisher pageSee results (8)

More studies

3 studies on this page

PubMed tag: none · 2017

Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects.

Bays et al. 2017Current medical research and opinioncited by 38

PMID 27817208DOI 10.1080/03007995.2016.1251892PUB-27817208

Full text at the publisher
Publisher page

PubMed tag: none · 2017

Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials.

O'Neil et al. 2017Diabetes, obesity & metabolismcited by 93

PMID 28386912PMC5655710DOI 10.1111/dom.12963PUB-28386912

Free to read · publisher termsCC BY-NC-ND
Read at source

PubMed tag: none · 2017

Corrected

Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program.

Steinberg et al. 2017Diabetes carecited by 55

PMID 28473337DOI 10.2337/dc16-2684PUB-28473337

Full text at the publisher
Publisher pageRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 64 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Informed consent * Body mass index equal to or above 30 kg/m\^2 * Stable body weight (less than 5% self-reported change during the previous 3 months) * Diagnosis of moderate or severe obstructive sleep apnoea (OSA) * Unwilling or unable to use continuous positive airway pressure (CPAP) (or other positive airway pressure) treatment. No CPAP (or other positive airway pressure) treatment for at least four weeks prior to screening * Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, compliance to visit schedule and dietary advice and complete trial related questionnaires Exclusion Criteria: * Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 inhibitors or insulin within the last 3 months prior to screening * Diagnosis of type 1 or type 2 diabetes per judgement of the investigator * Glycosylated haemoglobin (HbA1c) equal to or above 6.5% * Significant craniofacial abnormalities that may cause OSA * Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator * Use of central stimulants, hypnotics, mirtazepine, opioids, trazodone within the previous 3 months prior to screening * Obesity induced by drug treatment * Treatment with pramlintide, sibutramine, orlistat, zonisamide, topiramate or phenteremine within the last 3 month prior to screening * Previous surgical treatment for obesity * Screening calcitonin equal to or above 50 ng/L * Familial or personal history of Multiple Endocrine Neoplasia type 2 or familial Medullary Thyroid Carcinoma * Personal history of non-familial Medullary Thyroid Carcinoma * History of chronic pancreatitis or idiopathic acute pancreatitis * History of Major Depressive Disorder or suicide attempts * Systolic blood pressure equal to or above 160 mmHg and/or diastolic blood pressure equal to or above 100 mmHg

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